Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in pancreatic cancer

BACKGROUND: Pancreatic cancer is a serious threat to human health. Ultrasound is widely used in screening or preliminary diagnosis of pancreatic cancer, and enhanced CT is widely used in the diagnosis of pancreatic cancer. However, false-positive results of ultrasound and enhanced CT will bring unnecessary mental pain, expensive examination costs, physical injuries, and even adverse consequences such as organ removal and loss of function; while false-negative results of enhanced CT bring delayed treatment, and patients will thus have to bear the adverse consequences of poor prognosis, high treatment costs, poor quality of life, and short survival period. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive rate of ultrasound and the false-negative and false-positive rates of enhanced CT in pancreatic tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in pancreatic cancer. MATERIALS AND METHODS: 62 subjects (malignant group, n=37; benign group, n=25) were finally included in this study. Remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively. RESULTS: The sensitivity of YiDiXie™-SS in pancreatic ultrasound-positive patients was 100% (95% CI: 90.6% - 100%) and the specificity was 60.0% (95% CI: 55.4% - 69.7%). Compared with enhanced CT alone, sequential use of YiDiXie™-SS and enhanced CT resulted in comparable sensitivity, but the false-positive rate decreased from 24.0% (95% CI: 11.5% - 43.4%) to 8.0% (95% CI: 1.4% - 25.0%). This means that the application of YiDiXie™-SS reduces the false-positive rate of ultrasound by 60.0% (95% CI: 55.4% - 69.7%) and reduces the false-positive rate of enhanced CT by 66.7% with essentially no increase in the leakage of malignant tumors.YiDiXie™-HS had a sensitivity of 85.7% (95% CI: 48.7% - 99.3%) and a specificity of 84.2% (95% CI: 62.4% - 92.5%) in enhanced CT-negative patients. This means that YiDiXie™-HS reduces the false-negative enhancement CT rate by 84.2% (95% CI: 62.4% - 92.5%). YiDiXie™-D has a sensitivity of 33.3% (95% CI: 19.2% - 51.2%) and a specificity of 100% (95% CI: 61.0% - 100%) in patients with positive enhancement CT. This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 100% (95% CI: 61.0% - 100%). CONCLUSION: YiDiXie™-SS significantly reduces the false-positive rate of ultrasound and enhanced CT in ultrasound-positive pancreatic patients with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS significantly reduces the false-negative rate of enhanced CT in patients with pancreatic tumors. YiDiXie™-D significantly reduces the false-positive rate of enhanced CT in patients with pancreatic tumors. The YiDiXie™ test has significant diagnostic value in pancreatic cancer, and is expected to solve the problem of "excessive false-positive rate of ultrasound", "enhanced CT" and "false-negative rate of pancreatic tumors" in pancreatic tumors. Clinical Research Registration Number:ChiCTR2200066840. Keywords: Pancreatic cancer, Ultrasound, Enhanced CT, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS, YiDiXie™-D